What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01158664
First received: July 7, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.


Condition Intervention
Dental Implants
Device: 0.6 mm tread pitch implant
Device: 0.1 mm tread pitch implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To document the outcome of bone remodeling around IBT implants [ Time Frame: 3 years after implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To clinically and radiographically document the placement of both IBT implant thread types in the same patient [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation [ Time Frame: over 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6 mm tread pitch implant Device: 0.6 mm tread pitch implant
0.6 mm tread pitch implant will be used
Experimental: 0.1 mm tread pitch implant Device: 0.1 mm tread pitch implant
0.1 mm tread pitch implant will be used

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Periodontally-healthy or periodontally-treated patients
  • Smokers are included
  • All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.

Exclusion Criteria:

  • All other contra indications for implant surgery
  • Guided bone regeneration or use of any substitutes
  • No implantation in regenerated or augmented bone
  • No immediate loading cases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158664

Contacts
Contact: Hugo De Bruyn, PhD hugo.debruyn@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Hugo De Bruyn, PhD         
Sub-Investigator: Eric Thevissen         
Sub-Investigator: Jan Cosyn         
Sub-Investigator: Stefan Vandeweghe         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01158664     History of Changes
Other Study ID Numbers: 2009/649
Study First Received: July 7, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
dental implants
different tread pitch design

ClinicalTrials.gov processed this record on August 25, 2014